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Overview of ISO 9000

ISO Objectives

The ISO 9000 Series Standards and Guidelines are one of several series of documents created, published and maintained by the International Organization for Standardization, located in Geneva, Switzerland. Use of this term before any of the various series supports the International Organization for Standardization's commitment to creating harmonious standards; in other words, standards that are appropriate, effective and useful by all membership countries. The ISO 9000 Series documents were not solely created by European interests but rather were the cumulative effort of many interested parties, including, but not limited to, the United States. Today, Technical Committees (TC) are delegated with the authority to maintain all "ISO" documents and are comprised of representatives from organization membership. TC 176 is responsible for evaluating and reviewing issues with the ISO 9000 Series Standards and Guidelines and is also responsible for publishing additional guidelines, as deemed appropriate by the various country members.

Unlike the many other ISO documents, the ISO 9000 Series documents are focused on continual improvement towards customer satisfaction THROUGH the use of an effective and efficient business management SYSTEM - a group of interrelated processes and activities that together serve to meet defined goals and objectives. The challenge facing most companies just starting this journey is to understand that the term "quality" is nebulous, defined only by the customer. The ultimate intent of the ISO 9000 Series Standards and Guidelines is to assist companies in serving their customers.

There are, to date, only three ISO 9000 Series Standards: ISO 9001, applicable for companies that have the capability to design; ISO 9002, applicable for companies who provide but do not design goods & services; and ISO 9003, focused on the final inspection and test processes within an organizations. It is highly likely, although not confirmed, that the intent of using ISO 9003 will be integrated into the use of ISO 9002, thereby resulting in only two standards, one for companies with design capability and one for companies without. The remaining documents are considered guidelines and aides to interpretation. Guideline documents include ISO 9000, ISO 9000-3, the guideline for companies who develop software; ISO 9004, a guideline for applying the requirements of ISO 9001 or ISO 9002. To date, there are at least a dozen guideline documents ranging from application in the health care industry to application in the service industry.

ISO Benefits

Although the primary driver of compliance to the ISO 9001 or ISO 9002 standards initiated in Europe during the rush for EC'92, a proliferation of interest was ignited when some companies began to realize that there were more benefits to implementing compliance to the standards then just a "requirement" being met. In fact, since 1987, when the first standard was issued, it is reported by some sources (e.g. CEEM, in Fairfax Station, Virginia) that more than 100,000 companies will pursue and obtain ISO 9001or 9002 certification by the end of this century. Although much of this is for the market advantage, some companies are also experiencing process improvements within their organization, resulting in greater efficiencies and effectiveness.

ISO Standards Motivation

a) Customer Requirements
Customers offering certain benefits and opportunities for ISO 9001 or 9002 registration is a key motivator for every organization.

b) Government/Regulatory Requirements
Within a small number of industries certain European Market requirements or "directives" require registration to one of the standards in order to obtain the CE mark and access to the European Union marketplace. Telecommunications, toys and medical and dental industries represent a portion of these. To determine if your industry is affected by a directive, contact the trade authority in Washington, D.C. or your industry lobbyist/representative.

c) Internal Benefits
Although not yet widely advertised, many companies have found that and on-going maintenance have provided substantial returns. One recent survey shows that most companies reaped a 100% ROI 3 1/2 years after registration. Returns most often arise in the areas of more efficient and effective processes and planning. With increased efficiencies, internal operating costs can decrease, thereby resulting in the ability to develop greater opportunities for the organization.
 

ISO Registration

ISO 9001 or 9002 compliance is achieved through effective and knowledgeable planning efforts. The first step is to obtain a copy of the appropriate standard, read it and use the over-abundant resources available today to discuss, learn and UNDERSTAND the requirements. Once this is done, the appropriate management team should consider the total ramifications of this journey and process and ensure that there is a shared vision of what is desired. With this, an implementation plan can be developed.

It is not necessary for a company to hire an external consultant nor is it appropriate or effective for a company to purchase an "off-the-shelf" solution. Typically, these types of solutions are very expensive and require considerable amount of time to customize for use. Good resources include books, software programs designed to teach you the requirements and related skills for implementing the requirements or other experienced professionals.

Test Drive iQ Company's Team Assessor with the ISO 9001 or ISO 9002 Assessment Modules.

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